Trump Sends Pharma Stocks Down with New Tweet on Drug Prices
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But they don't just price gouge. Drug companies need to file patents on their drug almost as soon as they sketch they come up with drug. From there they need at least 8 years to get through the FDAs approval process, so the manufacturers don't get nearly as much exclusive time with their IP as other industries. (They started getting around that by slightly tweaking the formula to last longer and calling it XL.) Plus they have to recoup the money they sank into other drugs that never made it to market. Sure, they can write down those losses, but a write-down ain't a refund.
If the government wants to start lowering drug prices, they can start by creating a special patent for the drug industry—call it a research patent—that can get converted to a regular patent when it gets FDA approval, and then give the drug companies the patent for the standard 20 years plus a renewal if they work the patent.
The next step: they can shorten time to market. We have evidence that the FDA errs too conservatively and doesn't approve (or delays) drugs that would have turned out totally safe and helped people. I remember they granted special approval to bring in a meningitis vaccine that Europe had for a while when an east coast school saw an outbreak. The vaccine still hadn't cleared the FDA, but I guess FDA special clearance is better than doing nothing. If it's safe enough for Western Europe, it's probably safe enough for Americans.
What are the manufacturing costs for software?
Our whole racket is based on pricing our services on value while pricing our cost of goods on production inputs.
It's not "fair" to let other industries do that right?
But how much do you value being alive? The "value" of a lifesaving drug is essentially unbounded, most people will pay anything to stay alive. That's one of the reasons healthcare is an edge case where the typical rules of capitalism don't work.
So yes, it is unfair to have some industries price their products based on "value".
> But how much do you value being alive? The "value" of a lifesaving drug is essentially unbounded, most people will pay anything to stay alive. That's one of the reasons healthcare is an edge case where the typical rules of capitalism don't work.
> So yes, it is unfair to have some industries price their products based on "value".
The problem with that logic is that taken to the extreme it means that everyone is entitled to every possible treatment, regardless of cost, and the rest of society must be the one that bears it.
If a treatment exists to extend the life of a terminally ill person for 1 more day at a cost of $100K should the rest of us pay for it? How about $1M? The numbers are purposely ridiculous but it's not that far out of reality.
At some point you need to draw the line and make the (not fun) decision of what's in and what's out.
I'm convinced the bulk of this could be solved with some common sense planning:
- Create an opt-in single payer plan at the federal level
- Use the existing Medicare booking codes for identification and list prices for covered treatments (prices to be paid to service providers)
- Service providers could opt in or out of the plans but couldn't do so on a per patient basis (i.e. similar to Medicare)
- Only include medication and treatments that are out of patent protection
- Only include medication that has at least N providers (was going to put three but may not exist for all generics)
Anything else would be purely out of pocket and not covered by the plan. Fyi, that last one means that if we started today, you'd have access to everything up to approximately 1997. I'm not a doctor and honestly don't know much about the medical field, but I'm pretty sure that pre-1997 medications should cover the vast majority of healthcare use cases.
I'd also propose a ban on drug marketing, which would reduce about half the costs.[1]
I don't think that excluding monopoly drugs will work. First, the industry has made significant progress in the past two decades, so for most major diseases, the leading treatment was patented within the last 20 years. Second, drug companies have little incentive to make direct competitors, and R&D effort is better allocated in areas with unmet medical need. Third, unpatented cures are already cheap, so by market size, almost all drugs are monopolies.
Over a third of the $333B pharmaceutical market[2] can be attributed to:
- Antibody drugs, $100B revenue and growing, almost all after 1997. E.g. Herceptin for HER2+ breast cancer, Humira for arthritis, Avastin for many cancers.[3,4]
- The cure for Hepatitis C is patented until 2028, and currently has $20B revenue.[5,6]
Disclaimer: I've worked in the industry.
[1] http://blogs.sciencemag.org/pipeline/archives/2013/05/23/ano...
[2] http://trade.gov/topmarkets/pdf/Pharmaceuticals_Executive_Su...
[3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4622599/
[4] http://www.prnewswire.com/news-releases/antibodies-market-no...
[5] http://www.pharmacompass.com/patent-expiry-expiration/sofosb...
[6] http://www.pharmacompass.com/radio-compass-blog/top-drugs-by...
The HepC treatment, while remarkably effective, would bankrupt most healthcare programs if they were forced to pay the retail price.
And if you take your idea to the extreme, then every person should have access to every type of medical care regardless of the value offered?
https://www.channel4.com/news/drugs-life-breast-cancer-nice-...
https://www.nice.org.uk/news/article/kadcyla-too-expensive-f...
NICE (National Institute for Health and Care Excellence) sets the guidance on the QALY (Quality Adjusted Life Year) at between 20000-50000GBP for a year's worth of a single drug treatment.
Of the drugs that they approve for coverage the annual regimen has to be under a threshold of 50000GBP or it may not be covered by the NHS.
But that 20000-50000GBP is per drug per person, someone could be on multiple drugs and treatments simultaneously for much more than that and they'll be covered.
"the U.S. Office of Management and Budget puts the value of a human life in the range of $7 million to $9 million" [1]
[1] https://www.theglobalist.com/the-cost-of-a-human-life-statis...
One data point from my experience:
- developer time to prepare, document a build, release notes
- build engineer to submit, check build, co-ordinate
- build machine hardware
- build machine OS license
- cryptographic signing hardware
- QA engineer time to test
- QA automation engineer's time to set up tests and maintain them
- QA test suite of machines for compatibility matrix
- technical writer for documentation
- distribution infrastructure / CDN
- support calls for new version
Another data point from my experience:
- about 2 minutes of developer time
- gratis open source build infrastructure
Its really not like they arrive one morning to the office, mix a few chemicals in a test tube, file a patent and then start selling them.
it's not- it doesn't matter- they're all the costs of getting a product to market and sustaining it.
High profit margins are not a bad thing, as long as people can still afford them. What we need is the proper type of regulations, I agree we need to streamline the fda process, but that alone is not going to solve things.
There are a few options I've heard, such as a special Patent for drugs which after ten years becomes a fair terms license Patent. Another one is that he government could exercise March in rights.
Are you sure about that? Shkreli himself disagrees with you, see his website:
Yes, most patients likely retained their access to the drug. The issue is more that we all wind up paying higher premiums so Shkreli can line his pockets with inflated proceeds and no alternatives.
It is apparently not in common use, Health Canada says that hospitals simply don't buy it anymore as of 2013, well before the price increase.
I suspect that if there's an entire first-world nation which no longer purchases the drug in hospitals or pharmacies, sales volume is probably pretty low in the U.S. I don't see what kind of premium increase you could attribute to that.
Once the virtual monopoly was obtained, he subsequently jacked up prices. In this he probably made a mistake by being way too greedy. With "ordinary" medication pricing, patients may not notice the very high prices, largely because American medical pricing is not terribly transparent. Instead, the higher costs tend to translate to higher insurance premiums and higher medical bills to the taxpayer.
Pyrimethamine is an old 1950s drug and as I understand it the synthesis is relatively easy. If the current American regulatory system wasn't so broken and we had a truly free market, Shkreli wouldn't even have a business plan with that sort of price increase, low volume notwithstanding.
The good news out of this is what Shkreli did was so egregious, the flaws in the system ended up being headline news.
What do you think the impact of withholding drugs from those that can't afford them could be?
>It costs a quarter to manufacture each pill but the manufacturers charge several dollars for that pill.
Is Trump writing checks to pay for R&D, salaries, etc? Of course they cost more than are to manufacture, that's the basics of business.
Unless we move to a heavily regulated single-payer system then these problems will continue. SP will negotiate with drug companies from a powerful position and be able to push down costs via policy. We keep seeing success with SP and socialized healthcare in Europe and elsewhere and somehow keep pretending the problem is too much regulation (?) or patents. Yet somehow Europe manages to thrive with those very same issues!
>We have evidence that the FDA errs too conservatively
The FDA has had public whistleblowers to stop dangerous drugs from getting approved. Its extremely arguable whether the FDA is either too conservative or too liberal or easily gamed by political pressure.
I'm honestly quite confused here. What solution, exactly, are you talking about? I don't remember proposing a solution.
In the Shkreli case, the drug price was raised in September 2015, and a cheap replacement was available on the market in October 2015 from a different company.
I don't believe Western Europe is any better in quality of drug vetting.
That's where the spending is concentrated, not in daily maintenance meds that cost a buck or two.
If I remember correctly, the average number of prescriptions for someone aged 65-79 is about four times the national average and since they treat chronic conditions due to aging, people take them until the day they die. Since Medicare isn't allowed to negotiate bulk prices for the prescriptions, the pharmaceutical companies pretty much get to charge whatever they want for critical drugs.
Just one of my 80 year old neighbors heart medications costs >$3000 per month and she's been taking it for almost 20 years, along with half a dozen other drugs. Cancer pills may cost a lot but the sheer scale of our aging population is much more relevant to overall healthcare costs.
As far as Medicare, they don't pay "whatever", they pay what everyone else pays or less.
I shouldn't have just said cancer drugs. Lots of specialty and small market drugs have enormous prices. Meanwhile, statins cost $0.30 a day: https://www.goodrx.com/lipitor
Medicare does pay less than other insurers but only because of a general law blacklisting companies that charge the government more than other customers (on the assumption that the govt will always be the single biggest customer but more susceptible to political influence). Drug companies keep this in mind when negotiating with insurers so it's nowhere near as effective as the NHS, which can't pass its costs onto consumers except through new legislation and negotiates for the entire UK population at the same time.
Giving pharmaceutical companies the full 20 years after approval, regardless of how long it took, would create a perverse incentive to patent early just to protect existing patent marketshare. It would also be extremely unfair to everyone else like the aviation/aerospace, semiconductor, and energy industries where it can easily take 5-10 years to get from patent to product and cost just as much. It's much better to subsidize research (which the public does on a massive scale already) and drive down the regulatory burden of approval, which we can do without decreasing safety by some targeted reforms of the FDA (mostly by giving it more power to organize clinical trial infrastructure and enforce transparency and trial integrity). Giving pharma more power is not the answer.
[1] https://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBu...
> If it's safe enough for Western Europe, it's probably safe enough for Americans.
Tell that to all the thalidomide kids in Europe. That's probably the best example of where the FDA saved a lot of lives.
https://www.forbes.com/sites/patrickcox/2016/12/14/trumps-fd...
https://www.bloomberg.com/politics/articles/2016-12-07/trump...
I'd like to see evidence for that. My impression, from all that I've read on the subject, the truth is quite the opposite. The FDA's funding has steadily been cut over the years and the restrictions on drug trials have been more lax over time. For example, drug trials have famously small sample sizes and are completely run by the companies themselves.
That's an odd criticism. Who would run the trial if not for the sponsor?
https://www.pharmacist.com/article/trump-calls-fda-slow-and-...
Why is it that much more expensive here?
Why Trump supporters think they can have the benefits of single-payer while attacking it and proposing a ridiculous healthcare bill is beyond me.
Americans subsidize drugs for the rest of the world.
Ventolin inhalers are apparently available over the counter in pharmacies in the UK - where does the government enter into that?
> if I went to the Doctor it would be free
probably reduces what people are willing to pay.
[NB Prescription charges aren't the same throughout the UK and where you do pay there is a long list of people who are exempt from paying]
Top 10 pharma companies, 5/10 are US (2 UK, 2 Swiss, 1 French).
4 of the top 6 for profit margins (from 43%(!) to 19%) are US (Merck is the only outlier, 9th, at 10%).
4 of the top 5 for Sales and Marketing Spend (both on raw dollars and as a percentage of revenue) are US.
3 of the bottom 5 for R&D spend (as a percentage of revenue) are US.
I think I see a little fat that can be trimmed in the name of our so-called subsidization...
http://www.eucope.org/lib/downloads/basic_facts_about_the_eu...
>4 of the top 5 for Sales and Marketing Spend (both on raw dollars and as a percentage of revenue) are US.
>3 of the bottom 5 for R&D spend (as a percentage of revenue) are US.
Say that $1 of marketing increases profits (exclusive of that $1) by $1.01. And you can do it 5 billion times before the effects cancel. In that case, it looks like virtually all of your money went to marketing, and yet there's no fat that can be trimmed.
Complete nonsense. I see this regurgitated again and again with nothing to back it up and it falls apart under the slightest inspection.
One of the Quora answers [1] to this question has lots of evidence and ultimately boils down to mostly marketing budgets (drugs are advertised directly to consumers here in the US and not elsewhere).
[1] https://www.quora.com/Does-the-US-subsidize-health-care-in-t...
Don't believe this one second. It's just self-serving nonsense to justify overcharging Americans.
This keeps being said, but I've never seen any support for it.
It's probably true to say that Americans subsidise the massive advertising budgets.
J&J, despite having 40% higher revenues ($70B vs $50B) spent nearly $2B less ($8.2B versus $9.9B) on R&D.
(I don't think the 'the US bears the burden' argument is especially compelling, I'm just saying that the country where a business is located doesn't reveal where it gets revenue)
Even with marketing spends of 20-25% of revenue, and R&D spends of 10% (and profit margins of typically 20%+), pharma has still managed to convince many Americans that they are struggling, and Americans are feeling the burden, of the US subsidizing the world's drug research (even though the two largest researching firms in the world aren't the US).
A Swiss company can get revenue from the US just as well as a US company. The location of their research lab won't reveal where they make their profits.
Basically, because the US is wealthy and much less regulated, drug companies from around the world make up a lot of their costs by selling things for more here, especially since private insurers have to pick up the tab in most cases.
Pharmaceutical companies in the S&P500 are so profitable because of barriers to entry, massive capital requirements, and a whole biotechnology industry feeding them acquisitions. Biotech startups going under with zero revenue after raising hundreds of millions of dollars from VCs and institutional investors is a regular occurrence. Since the brunt of the pure research is publicly funded and other investors chasing ROI take care of much of the R&D risk, big pharma companies benefit a lot from other people's money just for providing exit opportunities for smaller companies.
Why would a drug company spend money on DTC advertising if it "wasted" money? Your comment suggests they'd be better off not doing it at all.
The nation would be better off without the ads. They create an artificially inflated demand.
Doctors are the one's the write scripts, not drug companies. Are you saying doctors can't tell when a patient really needs a drug?
Europe has 8 different competing companies that make epipens, but the US only has only approved 2. And the second one has to be specifically prescribed or you get the more expensive name brand. And the company that makes it apparently gives bribes to generic manufacturers to keep them from competing. And spends lots lobbying congress to let them keep doing this.
Step 2: Tweet up a storm
Step 3: Profit
Also: "Johnson & Johnson and Merck & Co. have taken steps to increase transparency about their prices." - let me know when they disclose how much they spend on development of non-generic drugs to treat serious medical conditions, vs. their other expenses (such as advertising). According to [1], the numbers aren't pretty. And that's lumping all of 'research' together - subtract generics and cures for baldness and similar, and how much money is being wasted in medicine becomes even more apparent.
[1]: https://www.washingtonpost.com/news/wonk/wp/2015/02/11/big-p...
A decade or so ago there was a big push to import cheaper drugs from Canada. What did drug companies do? Put a cap on how much drug would be sold in Canada. Canadians ended up restricting exports so that they had enough drug for their own citizens.
With the extends royalty period have a required pricing structure that has a set price to prevent gouging.
Anyway, regardless, what if pharma was only slightly or moderately profitable instead of insanely profitable? I don't want to be snarky, but the "we're not doing it unless it makes us a very big bag of cash" model of business just seems counter to the idea that having access to good healthcare is a basic human right. This is what makes me want to just create a whole DARPA + universities + national labs sort of system that takes on a lot of that responsibility of developing and testing drugs that is driven by more than just profit.
Don't pay for failure if you care about that, but maybe we need a whole heck of a lot more throwing it at the wall than we have now. I can see some startups wanting to play where they cannot now.
[0]: https://www.thestreet.com/story/13684503/1/hillary-blasts-dr...
What exactly qualifies someone to be a 'drain the swamp' candidate? Because at first glance, they sure aren't it.
It's especially hard to imagine when the person claiming to be draining the swamp starts a new biz named "Swamp Filling and Expansion, LLC".
http://www.politifact.com/truth-o-meter/promises/trumpometer...
Promise kept - 5
Compromise - 1
Stalled - 1
In the works - 14
Promise broken - 0
"I'm going to issue our notification of intent to withdraw from the Trans-Pacific Partnership."
I am sure this was an incredible difficult problem to solve. The renegotiation will be a walk in the park.
“I am looking to appoint judges very much in the mold of Justice Scalia. I'm looking for judges — and I've actually picked 20 of them so that people would see.”
Again, another masterpiece, he managed to write 20 people on a list. Unbevlievable this creativity. And because everybody is so impressed by this the rest will be another walk in the park.
"Place lifetime ban on White House officials lobbying for foreign government."
Lobbyist aren't needed anymore anyway. The administration is now run directly by corporations. Again, genius idea, will save a lot of money.